Recruiting

Study on the Effectiveness of Durvalumab for Patients with Metastatic Breast Cancer in Early Chemotherapy Stages

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying metastatic breast cancer, which is a type of breast cancer that has spread to other parts of the body. The study is exploring the use of a treatment called durvalumab, also known by its code name MEDI4736. Durvalumab is a medication given through an infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to see if using advanced genetic testing to guide treatment decisions can help improve the time patients live without their cancer getting worse, compared to standard chemotherapy treatments.

Participants in the study will receive either the targeted treatment based on their genetic analysis or standard chemotherapy. The study will compare the outcomes of these two groups to determine which approach is more effective. The trial will involve regular monitoring and assessments to track the progress of the disease and the overall health of the participants. The study aims to provide valuable insights into whether personalized treatment plans based on genetic information can offer better outcomes for patients with metastatic breast cancer.

Throughout the study, the safety and effectiveness of the treatments will be closely monitored. The trial will also look at overall survival rates and how the cancer responds to the treatments. This research is part of a larger effort to improve treatment options for patients with metastatic breast cancer by using cutting-edge genetic analysis to tailor therapies to individual needs.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will provide a signed and dated, written informed consent. This is necessary before any study-specific procedures, sampling, or analyses can begin.
You must have a confirmed diagnosis of breast cancer that has spread to other parts of the body, known as metastatic breast cancer. This should be in the first or second line of chemotherapy treatment.
Step 2
Initial assessments
You will undergo a series of assessments to confirm eligibility. This includes having a measurable target lesion or disease that can be evaluated according to specific criteria.
A biopsy of the tumor or metastasis will be required, unless it is not feasible. In such cases, a previously collected sample may be used.
Step 3
Treatment assignment
Based on the results of a detailed genome analysis, you will be assigned to a treatment group. This analysis helps determine the most suitable treatment option for you.
The treatment may involve the use of targeted agents, which are medications designed to specifically attack cancer cells based on their genetic makeup.
Step 4
Treatment administration
If assigned to receive the medication **Imfinzi**, it will be administered as a solution for infusion. This means it will be given through a vein, a process known as intravenous infusion.
The dosage and frequency of administration will be determined by the study protocol and your healthcare team.
Step 5
Ongoing monitoring
Throughout the study, regular monitoring will be conducted to assess the effectiveness of the treatment and any side effects. This includes imaging tests and other evaluations.
Your overall health and response to treatment will be closely observed to ensure safety and to make any necessary adjustments to your treatment plan.
Step 6
Completion of the study
The study will continue until the estimated end date or until you decide to withdraw. Your participation is voluntary, and you can choose to leave the study at any time.
Upon completion, the results will be analyzed to determine the effectiveness of the treatment in improving progression-free survival, which is the time during and after treatment that the cancer does not get worse.

Who can join the trial?

12 criteria

Must be a woman with breast cancer confirmed by a tissue test.
Must have a cancer that can be measured or evaluated using specific medical guidelines.
Must provide a signed and dated written consent form before any study procedures.
Must have social insurance coverage.
Must have cancer that has spread (metastatic) or is at stage IV at diagnosis.
Must not have cancer with Her2 over-expression (a specific protein that can affect cancer growth).
Must have cancer that can be biopsied (a sample taken for testing), except if the cancer is only in the bones. If a new biopsy is not possible, an older sample may be used if it meets certain conditions.
Must be eligible for the first line of chemotherapy for metastatic cancer or currently receiving it with no more than 2 cycles completed at the time of biopsy.
If the cancer is HR+ (hormone receptor-positive), there must be a history of cancer returning or worsening during hormone therapy or within 12 months after stopping it.
If the cancer is HR+/HER2- (hormone receptor-positive and Her2 negative), must have received a specific treatment called palbociclib if applicable.
Must be 18 years or older.
Must have a WHO Performance Status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.

Who cannot join the trial?

3 criteria

Patients who do not have metastatic breast cancer in the 1st or 2nd line of chemotherapy cannot participate. Metastatic breast cancer means that the cancer has spread to other parts of the body.
Only female patients are eligible for this study. Male patients cannot participate.
Patients who are not part of the vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.

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Oncopole Claudius Regaud
Toulouse, France

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Investigated drugs

Targeted Agents
are specialized treatments designed to attack specific features of cancer cells. In this trial, these agents are chosen based on a detailed analysis of the patient's cancer at the genetic level. This means that the treatment is personalized, aiming to be more effective by focusing on the unique characteristics of the cancer cells in each patient. The goal is to stop the cancer from growing and spreading by interfering with the specific molecules involved in the growth and survival of cancer cells.
Maintenance Chemotherapy
is a type of ongoing cancer treatment given to help keep the cancer from coming back after it has responded to initial therapy. In this trial, maintenance chemotherapy is used as a standard treatment option to compare against the targeted agents. It involves using drugs that kill or slow the growth of cancer cells, and it is typically given over a longer period to help maintain the benefits achieved from earlier treatments.

Durvalumab

What is already known about the treatment

Targeted Agents – These medications are administered to patients with metastatic breast cancer, typically in the form of oral tablets or intravenous infusions, depending on the specific agent used. They are currently being studied in clinical trials to determine their effectiveness in improving progression-free survival when guided by high throughput genome analysis. The main therapeutic indication is for patients undergoing first or second-line chemotherapy for metastatic breast cancer. At the molecular level, these agents work by specifically targeting and inhibiting pathways that cancer cells use to grow and spread. They are classified pharmacologically as targeted therapies, which are designed to interfere with specific molecules involved in tumor growth and progression.

Investigated diseases

Metastatic Breast Cancer – Metastatic breast cancer is a stage of breast cancer where the cancer cells have spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. This spread occurs when cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system. The disease progresses as these cancer cells form new tumors in other organs, disrupting their normal function. Symptoms can vary depending on the organs affected but may include bone pain, difficulty breathing, or neurological symptoms. The progression of metastatic breast cancer can be influenced by various factors, including the biology of the cancer cells and the body's response. The disease is typically chronic, requiring ongoing management to control its spread and alleviate symptoms.